Impact of implementing a category 1 external quality assurance scheme for monitoring harmonization of clinical laboratories in Spain.

Carmen Ricós,Beatriz Boned,Francisco Ramón-Bauzá,Sandra Bullich,Margarida Simón,Elisabet González-Lao,Carlos Vilaplana,Xavier Tejedor-Ganduxé,Fernando Marqués,Zoraida Corte,Montse Ventura,Joana Minchinela,Carmen Perich,Rubén Gómez-Rioja,Marià Cortés,Ricardo González‐Tarancón ,Cecília Martínez-Brú ,Jv García-Lario ,Ángel Hermoza Salas ,Ma Antonia Llopis ,Pilar Fernández–Calle ,Jorge Díaz–Garzón ,Ma Pilar Fernández-Fernández

doi:10.1515/almed-2020-0008

Abstract

The objective of the present study was to examine the evolution of the analytical performance specifications (APS) used in External Quality Assurance (EQA) schemes, as well as the efficacy of a category 1 EQA scheme in monitoring the harmonization of clinical laboratory results in Spain. A review of the literature on the types of quality specifications used in schemes in other countries and their evolution was performed. In addition, a comparative analysis of the potential impact that different APS from eight countries had on clinical decision-making was made based on three measurands: sodium, thyroid-stimulating hormone (TSH), and activated partial thromboplastin time (aPTT). Harmonization of analytical methods was demonstrated by assessing whether average results deviated from the certified reference value of control materials within the APS derived from biological variation (BV). The APS used in EQA have evolved from state-of-the-art models to BV. Poor clinical decision-making would occur if the results accepted by some APS were applied. In Spain, only 2 of the 18 measurands studied are considered to be well harmonized. Closer collaboration between laboratories and analytical system providers would be required to resolve discrepancies.

Highlights

The main objective of clinical laboratories is to provide useful information for adequate clinical decision-making
The analytical performance specifications (APS) used in the category 1 scheme of the SEQCML, as well as those used in eight schemes in other countries, were applied to the theoretical test results for sodium, thyroid-stimulating hormone (TSH), and activated partial thromboplastin time. (3) Describing the degree of harmonization of laboratory test results in Spain by evaluating the results of the category 1 scheme of the SEQCML during four consecutive cycles
In 1996, a first survey conducted among 16 European External Quality Assurance (EQA) schemes revealed that most organizations used the state of the art as APS (Figure 1A)

Summary

Introduction

The main objective of clinical laboratories is to provide useful information for adequate clinical decision-making. Harmonization aims to guarantee the comparability of test results between different laboratories and healthcare systems. In this context, standardization is a further step that aims to make test results traceable to International System (IS) units by using a reference method or a standard calibration material. E., they should be standardized (in the case of measurands with available calibration standards and reference methods) or harmonized (in the absence of such standards) This would contribute to adequate clinical decision-making, regardless of the laboratory that performs the analytical tests. Results: Harmonization of analytical methods was demonstrated by assessing whether average results deviated from the certified reference value of control materials

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Results

Conclusion